Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316498
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-04-19
Brief Title:
Saccadic Eye Movements in Patients With Niemann-Pick Type C Disease
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Randomized Controlled Study of OGT 918 in Adult and Juvenile Patients With Niemann Pick C Disease
Status:
COMPLETED
Status Verified Date:
2007-08-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is done in conjunction with a trial conducted at Columbia University College of Physicians and Surgeons in New York and the Royal Manchester Childrens Hospital in England to examine the effectiveness of a new drug called OGT 918 for treating Niemann-Pick Type C NPC disease Patients with this genetic disorder do not transport lipids fatty substances in their cells resulting in problems of the liver spleen and brain An early sign of NPC is a reduced ability to move the eyes rapidly up and down or from side to side These voluntary eye movements are called saccades Patients in the OGT 918 trial who participate in this sub-study will have their saccadic eye movements measured to see if improvement occurs with OGT 918 treatment
Patients with Niemann-Pick Type C disease 12 years of age and older who are enrolled in the OGT 918 trial described above may be eligible for this study
Participants will have both vertical up and down and horizontal side to side saccadic eye movements measured at two time points before starting treatment with OGT 918 and after 12 months of treatment For the test patients sit in a chair with their head positioned as for a regular eye examination steadied by a chin cup and headrest and follow with their eyes a series of lights or laser spots moving on a screen at a distance of 1 meter 3 feet During the test patients wear either special recording glasses infrared goggles or special contact lenses for measuring eye movements A full eye evaluation lasts about 1 hour and each eye is evaluated twice The evaluations are separated in time by at least an hour and possibly a day
Patients with Niemann-Pick Type C disease 12 years of age and older who are enrolled in the OGT 918 trial described above may be eligible for this study
Participants will have both vertical up and down and horizontal side to side saccadic eye movements measured at two time points before starting treatment with OGT 918 and after 12 months of treatment For the test patients sit in a chair with their head positioned as for a regular eye examination steadied by a chin cup and headrest and follow with their eyes a series of lights or laser spots moving on a screen at a distance of 1 meter 3 feet During the test patients wear either special recording glasses infrared goggles or special contact lenses for measuring eye movements A full eye evaluation lasts about 1 hour and each eye is evaluated twice The evaluations are separated in time by at least an hour and possibly a day
Detailed Description:
None given verified by PI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-EI-0011 | None | None | None |